Medium RiskFDA Device

Smith & Nephew, Inc.: Complaints were received indicating that the outer label incorrectly identified the product as size "1" instead of "-1". The product contained within the package is size "-1"

Agency Publication Date: March 20, 2019

Affected Products

Product: smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 SIZE, STEM, REF 713552510

Batch Numbers: 11AM15163U, 11AM15184T, 11CM01097U, 15MM06466, 16EM13018, 16EM13035 & 18CM08027

Lot Numbers:

Numbers

Product: smith&nephew SMF(TM) HIGH OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1H SIZE, STEM, REF 713552511

11CM01091T, 11EM12764T, 11EM12764U, 13MM16036B, 14GM13037D, 15MM09360A, 15MM10833A, 18CM24036 & 18EM15257

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82193

Status: Resolved

Manufacturer: Smith & Nephew, Inc.

Manufactured In: United States

Units Affected: 2 products (58 units; 9 units)

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Sources: FDA iRES · Raw API Response

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